Safety and Feasibility of the Infinity Catheter for Radial Access

Stroke, Acute Clinical Trial

Official title:

Safety and Feasibility of the Infinity Guide Catheter for Neuro Interventional Procedures Using Transradial Access

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04553549
• Other study ID #: Pro2020000869
• Status: Completed
• Start date: October 1, 2020
• Est. completion date: October 30, 2022

Study information

• Verified date: December 2023
• Source: Rutgers, The State University of New Jersey
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective of this single arm study is to evaluate the safety and feasibility of the AXS Infinity LS (Stryker, Freemont, CA, USA) and AXS Infinity LS Plus (Stryker, Freemont, CA, USA) catheters during the transradial approach through a secondary use of the data collected during neurointerventional procedures. This includes evaluating the conversion rates to a transfemoral approach. A secondary aim of the study is to assess the radial artery occlusion rates post procedure.

Description:

Patients who are undergoing endovascular intervention will be enrolled into the study. Consent will be obtained for the procedure and for the use of their prospectively collected clinical data. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr). If the artery does not meet the size criteria, only a 6Fr sheath will be used, and the data recorded during the procedure will not be utilized for analysis in this study. The preoperative and postoperative care will be the same for all the patients. No tests will be done outside of standard of care.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: October 30, 2022
• Est. primary completion date: September 15, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Age group 18 years and above.
• Patients undergoing neuro-embolization using large bore catheters

Exclusion Criteria:

• Patients with Radial artery diameter less than 2.4 mm measured with Ultrasound
• Age<18
• Patients who have previous surgeries at either approach site which precludes the use of one of the approach sites
• Patients who has poor collateral circulation, Raynaud's phenomenon, radial loop, brachial or subclavian stenosis, aberrant origin of the subclavian artery
• Pregnant patients

Related Conditions & MeSH terms

• Arteriovenous Malformations
• Brain Aneurysm
• Brain Tumor
• Carotid Stenosis
• Cavernous Sinus Thrombosis
• Intracranial Aneurysm
• Intracranial Arteriovenous Malformations
• Sinus Thrombosis, Intracranial
• Stroke
• Stroke, Acute
• Thrombosis

Intervention

Device:
• Transradial approach
Patients who are undergoing endovascular intervention will be enrolled into the study. As the metrics analyzed in this study are already normally collected, this study can be considered as a secondary use of the data. The procedure will be done using standard criteria as per operator preference. All interventional cases at the study institution undergo a "radial first" approach, meaning that the access site of choice is the radial artery. The investigators will measure the radial artery size to ensure that the artery is greater than 2.4 mm in order to use the Infinity catheter (8Fr).

Locations

Country	Name	City	State
United States	University Hospital	Newark	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Rutgers, The State University of New Jersey

Country where clinical trial is conducted

United States, 

References & Publications (5)

Bertrand OF, Rao SV, Pancholy S, Jolly SS, Rodes-Cabau J, Larose E, Costerousse O, Hamon M, Mann T. Transradial approach for coronary angiography and interventions: results of the first international transradial practice survey. JACC Cardiovasc Interv. 2010 Oct;3(10):1022-31. doi: 10.1016/j.jcin.2010.07.013. — View Citation

Hamon M, Pristipino C, Di Mario C, Nolan J, Ludwig J, Tubaro M, Sabate M, Mauri-Ferre J, Huber K, Niemela K, Haude M, Wijns W, Dudek D, Fajadet J, Kiemeneij F; European Association of Percutaneous Cardiovascular Interventions; Working Group on Acute Cardiac Care of the European Society of Cardiology; Working Group on Thrombosis on the European Society of Cardiology. Consensus document on the radial approach in percutaneous cardiovascular interventions: position paper by the European Association of Percutaneous Cardiovascular Interventions and Working Groups on Acute Cardiac Care** and Thrombosis of the European Society of Cardiology. EuroIntervention. 2013 Mar;8(11):1242-51. doi: 10.4244/EIJV8I11A192. — View Citation

Jolly SS, Amlani S, Hamon M, Yusuf S, Mehta SR. Radial versus femoral access for coronary angiography or intervention and the impact on major bleeding and ischemic events: a systematic review and meta-analysis of randomized trials. Am Heart J. 2009 Jan;157(1):132-40. doi: 10.1016/j.ahj.2008.08.023. Epub 2008 Nov 1. — View Citation

Kolkailah AA, Alreshq RS, Muhammed AM, Zahran ME, Anas El-Wegoud M, Nabhan AF. Transradial versus transfemoral approach for diagnostic coronary angiography and percutaneous coronary intervention in people with coronary artery disease. Cochrane Database Syst Rev. 2018 Apr 18;4(4):CD012318. doi: 10.1002/14651858.CD012318.pub2. — View Citation

Snelling BM, Sur S, Shah SS, Khandelwal P, Caplan J, Haniff R, Starke RM, Yavagal DR, Peterson EC. Transradial cerebral angiography: techniques and outcomes. J Neurointerv Surg. 2018 Sep;10(9):874-881. doi: 10.1136/neurintsurg-2017-013584. Epub 2018 Jan 8. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Feasibility of TRA Intervention	The size of the radial artery will be measured and the transradial approach will be used. Notation will be also be recorded if conversion to TFA is used.	1 month
Secondary	Assess radial artery occlusion rates post procedure	Reverse Barbue Test and ultrasound	1 month
Secondary	Demographics	Patient demographics will be analyzed such as past medical history, HTN, HLD, Afib	1 month